Apr 7th, 2020
Starpharma today released its Appendix 4C – Quarterly Cashflow Report for the period ended 31 March 2020.
Starpharma’s cash balance as at 31 March 2020 was $36.1 million, an increase of $0.2 million compared to the previous quarter’s cash balance. Net operating cash outflows for the quarter were $0.9 million, or $6.0 million for the nine months to 31 March 2020. Starpharma’s strong cash reserves and clean balance sheet places the Company in a strong position to continue to progress its commercial and R&D activities in the current uncertain global environment of the COVID-19 pandemic.Read More
Mar 4th, 2020
Starpharma today announced that following the successful launch of the VivaGel® antiviral condom by Okamoto Industries, Inc. (TYO: 5122:JP; Okamoto) in Japan, Okamoto has sought an expansion to its licence territory for the VivaGel® condom. As a result, Starpharma has granted Okamoto marketing rights to a further 11 countries in Asia which include South Korea, Indonesia, Malaysia, Thailand, Singapore and the non-government China market.
Mar 2nd, 2020
Starpharma today announced that Mr David McIntyre has commenced as an independent non-executive director of Starpharma, effective 1 March. Mr McIntyre’s appointment follows a comprehensive Board renewal and search process. As advised at the Company’s last AGM, Mr Richard Hazleton will be retiring at the 2020 AGM in November, having served 13 years on the Company’s Board. The timing of Mr McIntyre’s appointment enables a smooth transition and handover between directors.
Feb 13th, 2020
Starpharma today announced that VivaGel® BV has been launched in Asia under the brand name BETADINETM BV Gel. The product has initially been launched in South East Asia, with further roll-out in additional Asian countries, as regulatory approvals are granted.
BETADINETM BV Gel will be available over-the-counter (OTC), without the need to see a doctor or obtain a prescription. Asia is the third region to launch VivaGel® BV and represents a large commercial opportunity with access to more than 1.5 billion women.Read More
Feb 12th, 2020
The Board of Starpharma is pleased to announce the appointment of Mr David McIntyre as an independent non-executive director, effective 1 March 2020.Read More
Feb 11th, 2020
Starpharma today announced it has received US$3 million (A$4.5 million) from AstraZeneca following the successful dosing of the first patient in the phase 1 clinical trial of AZD0466 (DEP® Bcl2/xL conjugate) in December.Read More
Jan 30th, 2020
In this issue:
>> VivaGel® BV launched in the UK
>> AstraZeneca first DEP® product enters the clinic; triggers US$3M milestone
>> DEP® cabazitaxel trial moves into phase 2 on positive results
>> Fleurstat BVgel marketing campaign; New Zealand launch planned
>> Dual strategy to achieve approval of the NDA in the US
>> Okamoto joins forces with Japanese government for STI prevention campaign
>> VivaGel® condom receives regulatory approval in Europe
>> DEP® docetaxel & DEP® cabazitaxel clinical trial case studies
>> DEP® irinotecan phase 1/2 trial
>> New candidate - DEP® gemcitabine
>> GMP DEP® facility licence
>> DEP® combinations add further value
>> Outlook, recent news & eventsRead More
Dec 30th, 2019
Starpharma today announced that AstraZeneca (LSE/STO/NYSE: AZN) has commenced a phase 1 clinical trial of AZD0466 (DEP® Bcl2/xL conjugate) and the first patient has been successfully dosed. The trial will recruit patients with a range of cancers and will be conducted at 4-5 US sites.Read More
Dec 16th, 2019
Starpharma today announced that it has received a $4.9M R&D tax incentive refund which relates to the costs of research and development during the 2019 Financial Year. The refund is in respect of eligible R&D activities across Starpharma’s portfolio, including DEP® and VivaGel®.Read More
Dec 10th, 2019
Starpharma today announced successful completion of the phase 1 component of its phase 1 / 2 trial for DEP® cabazitaxel. The trial met its objective of evaluating safety, tolerability and preliminary efficacy data, and identifying a recommended phase 2 dose of 20 mg/m2. The trial will now transition seamlessly into phase 2, with two new sites initiated and recruitment activities already underway.Read More
Nov 20th, 2019
Starpharma today announced that it has been granted marketing approval for the VivaGel® condom in Europe.
Nov 19th, 2019
Starpharma today notifies that its 2019 AGM will be held at 4pm on 21 November 2019 at RACV City Club, Level 2, 501 Bourke Street, Melbourne, Victoria.
The AGM will be recorded and available via webcast later that day. To access the webcast, participants can register via the following link:
Oct 31st, 2019
Starpharma today announced results for its next internal development candidate, DEP® gemcitabine.
Oct 30th, 2019
Starpharma today released its Appendix 4C – Quarterly Cashflow Report for the period ended 30 September 2019.
Starpharma’s cash balance as at 30 September 2019 was $36.8 million, with net operating cash outflows for the quarter of $4.6 million. The cash balance does not include the anticipated $4.9 million R&D tax incentive which is expected to be received during the December quarter.Read More
Oct 8th, 2019
Starpharma today announced that it has been invited once more to present at the 9th Annual Partnership Opportunities in Drug Delivery (PODD) conference in Boston, USA, on 7-8 October.
The PODD conference showcases the latest advances in drug delivery and provides networking opportunities with senior scientific and commercial executives from many of the major international pharmaceutical companies. This year’s PODD conference will be chaired by AstraZeneca’s Head of Drug Delivery, Dr Shawn Davis.Read More
Sep 26th, 2019
Starpharma today announced that that the U.S. Food and Drug Administration (FDA) has authorised the use of AstraZeneca’s DEP® Bcl2/xL conjugate AZD0466 in clinical trials under an investigational new drug (IND) application. This is the first DEP® candidate to reach this milestone from Starpharma’s multiproduct license with AstraZeneca.Read More
Sep 12th, 2019
Starpharma today announced that its patented clinical stage nanoparticle formulation, DEP® irinotecan, showed significantly enhanced efficacy benefits over standard irinotecan (Camptosar®) and olaparib (Lynparza®) alone and in combination, in an irinotecan-refractory HT-29 human colon cancer xenograft model.Read More
Sep 3rd, 2019
Starpharma today announced that it has received a further regulatory approval in an Asian country for VivaGel® BV. This approval follows multiple country approvals in the region as previously announced on 15 August 2019. Mundipharma will be rolling-out the product in Asia under the brand name BETADINETM BV Gel.Read More
Aug 29th, 2019
Starpharma today announced that treatment with a novel HER-2 Targeted DEP® conjugate from its internal Targeted DEP® program resulted in tumour regression and 100% survival in a preclinical human ovarian cancer model.Read More
Promising efficacy signals observed in ongoing DEP® trials, including DEP® cabazitaxel escalation phase
Aug 28th, 2019
Starpharma today announced that promising efficacy signals have been observed in its ongoing clinical trials for both DEP® cabazitaxel and DEP® docetaxel.Read More
Aug 15th, 2019
Starpharma today announced that it has received the first regulatory approvals in South East Asia for VivaGel® BV. Mundipharma will be rolling-out the product in Asia under the brand name BETADINETM BV Gel.Read More
Aug 8th, 2019
Starpharma today announced that it has received the necessary regulatory and ethics approvals and will commence its phase 1/2 clinical trial for DEP® irinotecan. The objectives of the trial are to evaluate the safety, tolerability and pharmacokinetics of DEP® irinotecan to define a recommended phase 2 dose (RP2D), and to determine anti-tumour efficacy of the product in select tumour types. DEP® irinotecan is the third DEP® product to enter the clinic from Starpharma’s internal portfolio with a fourth, partnered DEP® candidate, AZD0466, also set to enter the clinic later this year.Read More
Jul 1st, 2019
In this issue:
>> VivaGel® BV launched in Europe & Australia; US regulatory progress
>> VivaGel condom launched in Japan by Okamoto
>> DEP® docetaxel & DEP® cabazitaxel clinical trial update; DEP® irinotecan trial start & new data
>> Starpharma signs second commercial oncology agreement with AstraZeneca
>> AstraZeneca highlights AZD0466 at 2019 ASCO meeting & upcoming US FDA IND
>> Patent published for AstraZeneca Bcl2/xL DEP conjugates
>> DEP® radiotherapeutics
>> Outlook, recent news & events
Jun 27th, 2019
Starpharma today announced that VivaGel® BV has been launched in Europe under the brand name Betadine BVTM. The product has been launched in several countries in Europe, including Germany, with further roll-out in additional European countries during the year.
Jun 20th, 2019
Starpharma has been invited to present at the Macquarie Emerging Leaders Corporate Forum in Melbourne. The Macquarie Emerging Leaders Corporate Forum provides Starpharma with an opportunity to present to more than 100 investors from Melbourne and Sydney.Read More
Jun 12th, 2019
Starpharma announced the first patent for DEP® Bcl2/xL inhibitor conjugates, developed in collaboration with AstraZeneca, has been granted by the US Patent and Trademark Office. These patented DEP® Bcl2/xL inhibitor conjugates combine Starpharma’s innovative DEP® delivery technology with AstraZeneca’s novel Bcl2/xL inhibitors, which are being investigated for treating various cancers, including leukemias.
Jun 4th, 2019
Starpharma today announced that the VivaGel® condom has been launched in Japan under Okamoto’s leading and highly successful Zero Zero Three (003) brand. This is the first condom with antiviral coating in Japan and will also carry Starpharma’s VivaGel® brand.Read More
Jun 3rd, 2019
Starpharma today announced a Development and Option Agreement with AstraZeneca (LON: AZN) to progress the development of a Dendrimer Enhanced Product (DEP®) version of an undisclosed AstraZeneca major marketed oncology medicine. This is the second DEP® commercial agreement Starpharma has signed with AstraZeneca, the first agreement being a multiproduct licence which covers novel oncology drug candidates such as AZD0466 (a Bcl2/xL inhibitor).Read More
May 29th, 2019
Starpharma has been invited to present today at the UBS Australian Emerging Companies Conference - Healthcare and Biotech – in Sydney. The UBS Healthcare Conference provides Starpharma with an opportunity to present to approximately 100 institutional investors.Read More
May 24th, 2019
Starpharma today announced that its patented nanoparticle formulation, DEP® irinotecan, showed significant efficacy and safety benefits over leading colorectal cancer drugs irinotecan (Camptosar®) and cetuximab (Erbitux®), in the irinotecan-refractory HT-29 human colon cancer model.
These impressive results were despite the fact that these standard colorectal cancer (CRC) treatments, Camptosar® and/or Erbitux®, showed limited activity in this preclinical model.Read More
May 23rd, 2019
Starpharma has received formal feedback from the recent meeting held with the US FDA in relation to the approval for two related bacterial vaginosis (BV) indications - BV treatment and the prevention of recurrent BV in the United States.Read More
May 7th, 2019
Starpharma today announced that it will be presenting its DEP® platform at the 2nd Annual Drug Delivery West conference in San Francisco on 6-7 May 2019 (US time).
May 1st, 2019
Melbourne, Australia; 1 May 2019: Starpharma (ASX: SPL, OTCQX: SPHRY) has been invited to present today at the Macquarie Australia Conference in Sydney. The Macquarie Australia Conference is a leading investment event in Australia and attracts more than 800 investors from around the world, including Asia, Europe and North America.
Apr 16th, 2019
Starpharma today announced that VivaGel® BV has been officially launched in Australia by Aspen Pharmacare (Aspen) as Fleurstat BVgel. The product has undergone distribution across Australia and is already available in some pharmacies. It will be progressively rolled-out nationally over the coming weeks. This is the first launch of VivaGel® BV in the world and further launches by Mundipharma are expected in Europe in May/June this year.Read More
Apr 11th, 2019
Starpharma today announced that a meeting was held with the US FDA overnight as part of the process to clarify and address FDA’s request for confirmatory data prior to the approval of VivaGel® BV in the US. This meeting was attended by senior representatives of Starpharma as well as internationally recognised Key Opinion Leaders in BV, statisticians and the Company’s expert FDA regulatory consultants, which include former senior FDA clinical personnel.Read More
Apr 3rd, 2019
Starpharma will today present to institutional investors at the Goldman Sachs Tenth Annual Emerging Companies Conference in Sydney.
Mar 18th, 2019
In this issue:
>> Fleurstat BVgel - Australian launch
>> Mundipharma's European launch of VivaGel® BV
>> Mundipharma's international roll-out of VivaGel® BV
>> FDA meeting to discuss VivaGel® BV approval in the US
Download: Shareholder Update March 2019 (pdf file, 453kb)Read More
Mar 12th, 2019
Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that it has received a $4.0M R&D tax incentive refund which relates to the costs of research and development during the 2018 Financial Year. The refund is in respect of eligible R&D activities across Starpharma’s portfolio, including VivaGel® and DEP® programs. This amount was not included in Starpharma’s cash balance reported in the Company’s Interim Report for the half-year ended 31 December 2018.Read More
Feb 27th, 2019
Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its interim report and financial results for the half-year ended 31 December 2018.Read More
Jan 17th, 2019
In this issue:
>> FDA requests further data for VivaGel® BV approval in the US
>> Launch of VivaGel® BV in multiple territories
>> VivaGel® BV licensed to ITF Pharma in the US
>> VivaGel® condom approved in Japan
>> Clinical trials for internal DEP® products progressing well
>> Patent published for AstraZeneca-DEP® drugs: DEP® Bcl2/xL inhibitors show compelling efficacy & synergy in combination
>> DEP® docetaxel & DEP® cabazitaxel outperformed both gemcitabine & Abraxane®
>> SPL7013 eye drops for viral conjunctivitis
>> Partnering activities
>> Macquarie initiates coverage of Starpharma
Download: Shareholder Update January 2019 (pdf file, 557kb)
Jan 2nd, 2019
Melbourne, Australia; 2 January 2019: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that the VivaGel® condom has received final regulatory approval and is now able to be marketed in Japan, following the completion of the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) review of the product’s medical device classification and associated data. This final approval follows on from the previously granted regulatory certification, which was attained for the VivaGel® condom.
Dec 27th, 2018
Melbourne, Australia: Starpharma today received advice from the US FDA that it will require confirmatory clinical data prior to approving VivaGel® BV for treatment of bacterial vaginosis (BV) and the prevention of recurrent BV (rBV).Read More